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Syphilis Screen, Total Antibody

Synonym(s): Treponema pallidum, Reverse Algorithm, Syphilis Serology, Syphilis Total Antibody 
Requisition Form G-2A
Test Description Multiplex flow immunoassay for the qualitative detection of total (IgM and IgG) antibodies to Treponema pallidum in human serum. 
Pre-Approval Needed N/A
Supplemental Information Required N/A
Supplemental Form(s) N/A
Sample/Specimen Type for Testing Serum
Minimum Volume/Size Required 500 µL
Storage/Preservation Prior to Shipping
  • Store at 2°C to 8°C for up to 5 days 
  • For storage longer than 5 days, store at – 20°C or below.
Transport Medium N/A
Specimen Labeling
  • Two patient-specific identifiers required on specimen (e.g., patient full name, date of birth, medical record number). 
  • Three patient identifiers are preferred. 
  • Patient identifiers on specimen label must exactly match identifiers on submission form (e.g., abbreviated name on label and full name on form is not acceptable). 
  • Additional DSHS Laboratory specimen labeling guidelines available online here. 
Shipping and Specimen Handling Requirements
  • Ship according to Dangerous Goods Regulations, IATA, and/or CFR 49. 
  • Category B Biological Substance, UN3373 shipping requirements apply.  
  • Handle as infectious agent using universal precautions.  
  • Triple-contain in accordance with federal shipping regulations for infectious agents.  
  • Submitters are responsible for packaging and shipping specimens according to regulatory requirements.  
  • If specimens will arrive at the Lab within 5 days of collection, refrigerate at 2°C–8°C and ship overnight on cold packs. 
  • If specimens will arrive at the Lab more than 5 days after date of collection, freeze at -20°C or below, and ship overnight on dry ice. 
  • Additional DSHS Laboratory specimen shipping guidelines online here.  
Method Multiplex flow immunoassay 
Turn-around Time 3 working days
Interferences/Limitations
  • Contaminated, icteric, hemolyzed or heat inactivated serum may cause erroneous results and should be avoided.
  • Cross-reactivity with other treponemal disease conditions, such as yaws, pinta, or bejel is to be expected with treponemal antibody tests.
Common Causes for Rejection
  • Insufficient specimen quantity.
  • Unacceptable specimen type or source.
  • Improper shipping conditions.
  • Expired media or collection container.
  • Expired reagents/media/collection container. 
  • Discrepancies between G-2A submission form and specimen label. 
  • Missing/incomplete/illegible submission form or label.
Additional Information
  • A non-reactive result does not exclude the possibility of exposure to or infection with T. pallidum. 
  • Detection of treponemal antibodies may indicate recent, past, or successfully treated syphilis infection. 
  • The Syphilis screen is the first test in the syphilis testing algorithm.  Reactive specimens will automatically reflex to RPR testing followed by TP-PA testing for discordant results between the screen and RPR test.